Events

Retiro De Equipo (Recall) de DILUENT UNIVERSAL

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ROCHE DIAGNOSTICS.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    23128
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-02-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    This recall is related to a potential reduction in the signal of the elecsys cmv igm assay when used in combination with some specific lots of diluent universal which may lead to false negative results for patients samples with high reactivity against one specific antigen included in the assay. therefore patient samples having also a high reactivity against this specific antigen may be affected by reduced cut-off values which may lead to a false negative result when the affected combination is used. the signal reduction has only minor effects on the calibrators and controls.

Device

DILUENT UNIVERSAL
  • Modelo / Serial
    Model Catalog: 03183971122 (Lot serial: 176899); Model Catalog: 03183971122 (Lot serial: 175913); Model Catalog: 11732277122 (Lot serial: 175913); Model Catalog: 03183971122 (Lot serial: 178383); Model Catalog: 11732277122 (Lot serial: 178383); Model Catalog: 03183971122 (Lot serial: 178386); Model Catalog: 11732277122 (Lot serial: 178386); Model Catalog: 03183971122 (Lot serial: 180209); Model Catalog: 11732277122 (Lot serial: 183653); Model Catalog: 03183971122 (Lot serial: 183653); Model Catalog: 11732277122 (Lot serial: 176899); Model Catalog: 11732277122 (Lot serial: 176099); Model Catalog: 03183971122 (Lot serial: 176099); Model Catalog: 11732277122 (Lot serial: 183652); Model Catalog: 03183971122 (Lot serial: 183652); Model Catalog: 11732277122 (Lot serial: 180209); Model Catalog: 04784618190 (Lot serial: 182962); Model Catalog: 04784618190 (Lot serial: 179689)
  • Descripción del producto
    DILUENT UNIVERSAL
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Dirección del fabricante
    LAVAL
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    HC